Senior Manager, Regulatory Operations
About The Position
Reporting to the Director, Regulatory Affairs Project Management and Operations, the Senior Manager, Regulatory Operations provides key support to the Nurix Regulatory Affairs department. This position has responsibility for entry-level coordination, review, assembly and archival of regulatory submissions in Veeva RIMS and documents for health authorities (US FDA and global equivalents). The Senior Manager, Regulatory Operations will provide support for multiple regulatory activities, studies, and programs. The individual will have responsibility to understand and implement regulatory guidance and help ensure regulatory compliance for assigned projects. The Senior Manager should have 5 years’ experience in Regulatory Affairs or Regulatory Operations. Working knowledge of at least one functional discipline (e.g. Regulatory, Clinical, Nonclinical, Clinical Pharmacology or Chemistry Manufacturing and Controls) and a general knowledge of clinical development preferred. The candidate should have a can-do attitude and experience working in Veeva RIMS. Also, the candidate should be eager to learn regulatory and clinical trial requirements, best practices, and provide support for Regulatory programs and leadership.
Requirements
- Bachelor's Degree in Life Sciences or relevant field
- Minimum of 5 years’ experience working in Regulatory Affairs or Regulatory Operations. Additional experience in the biotechnology or pharmaceutical industry preferred
- Understanding of the drug development process
- Proficient knowledge of Veeva RIMS SCP, workflows, archival, reporting…
- Experienced publisher (DocuBridge, GlobalSubmit, VeevaVault Submission…)
- Experience successfully supporting critical deliverables while maintaining agreed timelines
- Demonstrated ability to work effectively with cross-functional teams or collaborative environments.
- Basic knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
- Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
- Superior communication skills: oral, written, with proven negotiation skills, and strong time-management.
- Excellent Computer Skills MS Word, Excel, Power Point, Smartsheet and document management software/system, templates.
- Ability to work on multiple tasks and prioritize tasks to meet company objectives. Strong attention to detail and time management skills are essential.
Nice To Haves
- General knowledge of clinical development preferred
- Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus.
- Previous experience with maintaining in-house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (e.g., Veeva) is a plus.
Responsibilities
- Under the strategic direction of the SVP of Regulatory Affairs and the Director of Regulatory Affairs PM and Operations, the candidate will support the planning, coordination, tracking and execution of submissions and responses to global regulatory authorities
- Assist Regulatory team, project teams and Clinical Research Organization (CRO) counterparts in the implementation of regulatory plans, timely delivery, and submission of regulatory documentation
- Preparation of Regulatory submission documentation (e.g Forms, Cover Letter) as requested
- Support team with formatting, QC and publishing of submission documents and packages
- Manage and support Veeva RIMS processes such as HAI, SCP and Archiving
- Manage authoring and review workflow in Veeva RIMS according to defined timelines
- Coordinate with regulatory colleagues and cross-functional departments to prepare, compile, review, and submit documents or information necessary to health authorities in accordance with regulations, guidelines or queries IN Veeva RIMS using SCP
- Maintain archival copies of health authority submissions (e.g., IND, CTA, NDA, and MAA), correspondence and a record of health authority obligations, and commitments
- Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration. Participate in Regulatory Intelligence activities to help inform team members of new applicable guidelines and conduct training sessions on new guidelines/regulations if necessary
- Participate in kick-off and project-based meetings related to regulatory submissions, strategy, and comment resolution. Be a reliable resource for information following such meetings
- Follow general instructions from Regulatory management or company leadership for assigned projects while independently planning daily work tasks to complete projects on time. Seek guidance on project/task priorities as needed
- Communicate important project decisions or challenges to Regulatory leadership
- Create or contribute to Standard Operating Procedures (SOP), checklists and training Materials for Regulatory department activities
- Support contracts and Purchase order for the Regulatory Affairs department
Benefits
- bonus & equity
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What This Job Offers
Job Type
Full-time
Career Level
Senior
